Use of device for measuring cervical and uterine activity for diagnosis of labor and related conditions

Inactive Publication Date: 2015-08-06
THE JOHN HOPKINS UNIV SCHOOL OF MEDICINE +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method for detecting uterine and cervical activity in a subject using a medical device that is positioned within the subject. The device has electrodes that are in contact with the cervical and vaginal surfaces, and the electrical activity of these surfaces is measured using the electrodes. The method can be used to detect pre-term labor, identify the source of pelvic pain due to uterine contractions, and predict the likelihood of success of in-vitro fertilization treatment. The technical effects of the invention include improved accuracy in detecting uterine and cervical activity and improved accuracy in predicting outcomes related to pre-term labor and in-vitro fertilization treatment.

Problems solved by technology

Despite recent technological medical breakthroughs, the issue of diagnosing preterm labor has continued to plague the obstetric community.
Preterm births lead to 70% percent of neonatal morbidity and mortality, and cost the United States over $26.2 billion in 2005 alone.
Currently there is no way of accurately detecting preterm labor, which often leads to preterm birth.
Tocodynamometry (TOCO) is the mainstay for preterm labor evaluation but most clinicians would agree it has limited utility before 26 weeks gestation.
The obesity epidemic has further reduced our ability to accurately detect uterine contractions using TOCO at any gestational age (GA) due to the excess tissue interfering with contraction detection.
These issues prevent timely diagnosis and treatment of preterm labor.
A method and device that detects preterm labor early in its course in patients is currently lacking.
Preterm delivery does not allow the fetus enough time to develop within the womb, resulting in severe short and long-term health issues for the neonate.
All of the current methods available for detection of cervical and uterine activity are ineffective, insufficient, or inaccurate.
Transvaginal ultrasound, while able to detect cervical changes even at very early gestational ages, cannot usually detect the contractions that are often present before these changes are evident.
Symptomatic monitoring is insufficient because patients do not present for evaluation until the time for meaningful intervention has passed.

Method used

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  • Use of device for measuring cervical and uterine activity for diagnosis of labor and related conditions
  • Use of device for measuring cervical and uterine activity for diagnosis of labor and related conditions
  • Use of device for measuring cervical and uterine activity for diagnosis of labor and related conditions

Examples

Experimental program
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Effect test

example 1

[0100]Use of UCAM with a Patient. According to one embodiment, the UCAM 100, 200, 302 may be adapted to be applied directly to the cervix by the clinician. For example, when a symptomatic or high-risk patient visits her physician for a weekly or bi-weekly routine check-up, she may undergo a series of tests, including monitoring via a tocodynamometer, a digital examination and / or a transvaginal ultrasound to assess cervical length. This evaluation can last from two hours to 24 hours while the woman is probed and monitored. The disposable cervical elastic ring portion of the UCAM may be placed on the cervix of the patient after the initial digital examination, and remain for the full duration of the observation period. This may allow the physician to closely monitor the patient's dilatation, effacement, and contractions without constantly being in attendance. The readings may be provided by a separate monitor and saved to a hard-drive. At each evaluation for preterm labor, the patient...

example 2

[0102]Direct Application to the Cervix. According to an embodiment, the UCAM 100, 200, 302 may be comprised of flexible, biocompatible and sterilizable components that conform to a normal pregnant cervix. The outputs that address these inputs may be realized in the design of the cervical ring through the specified characteristics of materials, fixation points and overall form factor.

[0103]According to one embodiment, the elastic ring 108 may have an initial inner diameter of approximately 20 mm and a stretched inner diameter of approximately 40 mm. The flexible band may have a thickness of approximately 4 mm and a depth of approximately 10 mm. Each wing portion may have a width of approximately 10 mm and a depth of approximately 7 mm.

[0104]According to another embodiment, the UCAM may be made of biocompatible medical grade polymer, for example, but not limited to, a medical grade silicone elastomer. The optimal Young's modulus, sometimes referred to as the elastic modulus or modulus...

example 3

[0105]Direct Detection of Cervical / Uterine Activity. According to one embodiment, the UCAM 100, 200, 302 may be comprised of uterine contractility sensors (measuring cervical and vaginal electrical potential), effacement sensors (measuring tissue thickness) and dilatation sensors (measuring diameter). The outputs that address these inputs are realized in the selection of the cervical ring sensors through the specified characteristics and placement of the selected electrodes, LED emitter and detector pair and embedded stretch gauge.

[0106]According to another embodiment, unipolar electrodes may be used to detect both cervical and uterine contractions and / or electric potentials. Such electrodes may be made from, for example, 316L stainless steel and / or sintered silver chloride (Ag—AgCl). The electrodes may have an approximately 8 mm diameter. According to one embodiment, the electrodes may comprise EMG electrodes having a measurement range of approximately 50 to 3000 Hertz. According t...

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Abstract

Methods for detecting uterine and / or cervical activity in a subject are disclosed which comprise positioning a “uterine / cervical activity monitor” or “UCAM” within the subject, wherein at least one structural component of the UCAM is structured to be in contact with a cervical surface and / or a vaginal surface of the subject and which receives an electrical activity of said cervical surface and / or which receives electrical activity of the uterus through said vaginal surface and processing the electrical activity of said cervical and / or vaginal surfaces using a data processor in communication with the UCAM to detect uterine and / or cervical activity of the subject. The methods and UCAM device disclosed herein can be used to detect pre-term labor, differentiate non-labor contractions from “true” labor, as well as other indications.

Description

REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Patent Application No. 61 / 935,567, filed on Feb. 4, 2014, which is hereby incorporated by reference for all purposes as if fully set forth herein.STATEMENT OF GOVERNMENTAL INTEREST[0002]This invention was made with government support under grant no. HD072684, awarded by the National Institutes of Health. The government has certain rights in the invention.BACKGROUND OF THE INVENTION[0003]Despite recent technological medical breakthroughs, the issue of diagnosing preterm labor has continued to plague the obstetric community. In order to fully understand the gravity of this need, it is important to recognize the regrettable outcomes and heavy costs related to preterm birth. Preterm births lead to 70% percent of neonatal morbidity and mortality, and cost the United States over $26.2 billion in 2005 alone. Currently there is no way of accurately detecting preterm labor, which often leads to pre...

Claims

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Application Information

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IPC IPC(8): A61B5/00A61B5/0488
CPCA61B5/435A61B5/04882A61B5/6875A61B5/0084A61B5/4356A61B5/391
InventorAINA-MUMUNEY, ABIMBOLAHWANG, KARINSUNWOO, NATE S.
OwnerTHE JOHN HOPKINS UNIV SCHOOL OF MEDICINE